BILL NUMBER: S3230

SPONSOR: HOYLMAN-SIGAL
 
TITLE OF BILL:

An act to amend the public health law, in relation to adding "embryo" to
the definition of "tissue" for purposes of tissue storage

 
SUMMARY OF SPECIFIC PROVISIONS:

Section 1 amends subdivision 10 of Section 4360 of the public health law
to add "embryo" to the definition of tissues covered by the tissue bank
and storage facility licensing law.

Section 2 establishes the effective date.

 
JUSTIFICATION:

In vitro fertilization, commonly known as IVF, is an accepted and widely
used method of assisted reproductive technology (ART). ART has helped an
estimated six million couples in the United States who have trouble
getting pregnant or maintaining a pregnancy start families. IVF provides
              

a pathway to motherhood for women who have experienced life-threatening
diseases, such as cancer, and the reproductive damage that is often a
consequence of the treatments associated with these illnesses. It also
provides the same pathway for couples, regardless of sex or sexual
orientation, and is often a critical service to transgender individuals.
It is anticipated that by the end of the century, more than a million
American patients who suffer from some form of fertility issue will
undergo IVF procedures.

The public interest in adequately protecting the human embryo tissue
bank and storage facility industry is of the highest importance. Many
populations depend on these facilities to protect their ability to have
children. The safe, effective regulation of embryo tissue banks and
storage facilities is critical to meeting this need. Under current law,
embryos are not defined in the list of types of tissues that may be
included in tissue bank and storage facilities. However, the New York
State Department of Health includes embryos in their list of tissues
that they regulate. This bill would add embryos to the definition of
"tissue" under Section 4360 of the Public Health Law, thereby confirming
the regulatory authority of the Department of Health in statute.

Additionally, Due to the increasing use of IVF and the advances in the
science of embryo storage, the Commissioner of Health should consider
modernizing and updating New York's regulations on embryo storage to
incorporate new guidance including standards ISO 9001 and ISO 20387 of
the International Organization for Standardization, the standards for
biorepositories established by the International Society for Biological
and Environmental Repositories and by the College of American Patholo-
gists Biorepository Accreditation Program, and the FDA's guidance on
"current good tissue practices."

These standards are accepted best practices for protection of embryos,
as well as for protection of the public interest in these important
facilities.

 
PRIOR LEGISLATIVE HISTORY:

S.0568 of 2021-2022 (Hoylman): Died in Health

A.1135 of 2021-2022 (Paulin): Advanced to Third Reading Calendar

S.5032-A of 2019-2020 (Hoylman): Died in Health

A.7214 of 2019-2020 (Paulin): Died in Rules

 
FISCAL IMPLICATIONS:

None to the state.

 
EFFECTIVE DATE:
This act shall take effect immediately.